Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis

Aphthous Stomatitis Clinical Trial

Official title:

Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293968
• Other study ID #: qums353
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2011
• Last updated: May 16, 2012
• Start date: November 2010
• Est. completion date: February 2011

Study information

• Verified date: May 2012
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)

Description:

Recurrent aphthous stomatitis (RAS) is the most painful oral lesion with a considerable prevalence . The most common aphthous ulcer treatments include applying topical agents such as antibiotics, Non Steroidal Anti Inflammatory Drugs (NSAIDs) to immunosuppressants.

The mixture of Diphenhydramine and Aluminum MgS suspension has been prescribed as an analgesic mouthwash for a long time in order to decrease a great number of oral ulcers symptoms such as aphthous ulcers. Ibuprofen is a potent NSAID with fair anti-inflammatory potential prescribed in dental pains.

This double-blind randomized clinical trial was conducted to assess the effect of Ibuprofen, Diphenhydramine and Aluminium MgS mixture on symptoms of aphthous ulcers.40 patients will be participating in this study,20 will receive the mixture of Diphenhydramine and Aluminium MgS while the other group will receive Ibuprofen, Diphenhydramine and Aluminium MgS mixture.

All patients will be instructed to apply the drug on the site of the ulcer 30-60 minutes before meals, 3 times daily. The ulcers will be assessed when the drug is applied for 3 days and the level of pain and irritation will be estimated by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• possessing at least one painful aphthous ulcer in the last 3 days

• older than 10 years of age

Exclusion Criteria:

• systemic disease or specific syndrome (such as Behcet's)

• pregnancy

• breastfeeding

• allergy to NSAIDs

• history of asthma, peptic ulcers, hepatic and renal failures and hemorrhagic disorders

• consumption of anti-inflammatory medications in the last 24 hours

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Aphthous Stomatitis
• Stomatitis
• Stomatitis, Aphthous

Intervention

Drug:
• Ibuprofen, Diphenhydramine and Aluminium MgS
3 times daily for 3 days
• Diphenhydramine and Aluminium MgS
3 times daily for 3 days

Locations

Country	Name	City	State
Iran, Islamic Republic of	Dental faculty of Qazvin University of Medical Sciences	Qazvin
Iran, Islamic Republic of	Qazvin University of Medical sciences	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation	pain sensation was measured by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain)) 4 days after the consumption of the solution	four days after the start of the study	No
Secondary	The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation	pain sensation was measured by VAS (Visual Analogue Scale) 4 days after the consumption of the solutions and the results of both drugs was analyzed	4 days after the solution consumption	No